NMF-CsA-Dupi Trial

NCT04878770 | Unknown

• 2 other identifiers: MEC-2019-05682019-003247-30
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to investigate whether stratification of children with atopic dermatitis on the NMF biomarkers results in an improvement of effectiveness and efficiency in the use of systemic treatment (ciclosporin and dupilumab) in moderate-to-severe atopic dermatitis.

Conditions

Dermatitis, Atopic

Keywords

natural moisturizing factor; systemic treatment

Outcome Measures

Primary Outcomes (1)

• EASI

  Change from baseline Eczema Area and Severity Index (0-72) over the course of 6 months, with higher scores meaning worse outcomes.

  t = 0, 1 month, 2 months, 3 months and 6 months

Secondary Outcomes (6)

• EASI75

  t = 1 month, 2 months, 3 months and 6 months

• IGA 0 or IGA 1

  t = 0, 1 month, 2 months, 3 months and 6 months

• NRS-11 reduction for itch ≥ 4 points

  t = 0, 1 month, 2 months, 3 months and 6 months

• POEM

  t = 0, 1 month, 2 months, 3 months and 6 months

• SCORAD

  t = 0, 1 month, 2 months, 3 months and 6 months

Other Outcomes (14)

• CDLQI ≥4 years

  t = 0, 3 months and 6 months

• IDQoL <4 years

  t = 0, 3 months and 6 months

• Emollients and steroid use in frequency and tubes used

  t = 0, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months

Study Arms (3)

Topical corticosteroids (control)

ACTIVE COMPARATOR

This group will receive topical corticosteroids.

Drug: Topical corticosteroids

Systemic cyclosporine

ACTIVE COMPARATOR

This group will receive topical corticosteroids and systemic cyclosporin.

Drug: Topical corticosteroids; Drug: Systemic cyclosporine

Systemic dupilumab

ACTIVE COMPARATOR

his group will receive topical corticosteroids and systemic dupilumab.

Drug: Topical corticosteroids; Drug: Systemic dupilumab

Interventions

Topical corticosteroids DRUG

Topical corticosteroids (TCS) are registered for patients of all ages, and are together with emollients, the pillars in the basic treatment of atopic dermatitis. In this study, patients in both the intervention groups and control group are treated with daily emollients and a TCS of moderate to high potency if needed. Rescue medication with TCS of higher potency may be prescribed if basic therapy is inadequate in controlling AD symptoms.

Systemic cyclosporine; Systemic dupilumab; Topical corticosteroids (control)

Systemic cyclosporine DRUG

Systemic cyclosporine A (CsA) is an immunosuppressive therapy and is a registered treatment for AD in adults. According to national guidelines, CsA is the first choice for systemic treatment in children with moderate-to-severe AD. For CsA a starting dose of 4-5mg/kg/day is administered orally and then tapered down to 2-3mg/kg/day depending on clinical effect. Two doses will be taken at two fixed times per day. Treatment with systemic CsA will be continued for a total of 6 months.

Also known as: Neoral

Systemic cyclosporine

Systemic dupilumab DRUG

Dupilumab (DUPIXENT) is indicated for the treatment of children of 6 years and older with moderate-to-sever atopic dermatitis whos disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. rm: Active Comparator: Systemic dupilumab Dupilumab (DUPIXENT) is administered as a solution by subdermal injection according to national guidelines, based on age and body weight.

Also known as: DUPIXENT

Systemic dupilumab

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents, aged 2-18 years, with moderate-to-severe atopic dermatitis (diagnosed according to the UK working party criteria)
• Patient and parents/guardians able to participate in the study and willing to give written informed consent
• EASI (Eczema Area Severity Index) ≥ 6 at screening and baseline (corresponding with moderate-to-severe disease)
• IGA (Investigator Global Assessment) ≥ 3 at screening and baseline (corresponding with moderate-to-severe disease)

You may not qualify if:

• Children under the age of 2 years and patients older than 18 years
• Contraindication for ciclosporin
• Contraindication for dupilumab
• Patient (or one of the parents/guardians) not willing to be randomized
• Children with a history of any known primary immunodeficiency disorder
• Children with a history of cancer
• EASI \< 6 at screening or baseline
• IGA \< 3 at screening or baseline

Sponsors & Collaborators

• Erasmus Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Erasmus MC - Sophia Children's Hospital

Rotterdam, South Holland, Netherlands

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Adrenal Cortex Hormones; Cyclosporine; dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Suzanne G.M.A. Pasmans, Prof

CONTACT

+31 6 53524299; s.pasmans@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Personnel involved assessing disease severity are blinded for the NMF biomarker result.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. S.G.M.A. Pasmans, MD PhD

Model Details: This is a partially-blinded randomized controlled trial that investigates if NMF-biomarker status has an effect on the effectiveness of systemic treatment with CsA in children with moderate-to-severe AD. It also investigates whether stratification on the NMF biomarker results in an improvement of efficiency in the use of systemic treatment with CsA in the treatment of moderate-to-severe AD.

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 7, 2021
• Study Start: August 16, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)